Medex
44 catalogue numbers from MX815E, listed by ICU Medical, Inc, United States, under Filter, Infusion Line. 1 manufacturer in China is registered for this product code.
1manufacturer
44catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FPB |
| Device type | Filter, Infusion Line |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K790314 |
| Record published | 2016-10-13 |
| Record revised | 2025-04-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, case of 10, case of 20, case of 50, box of 25, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX815E | In distribution | |
| SM5009 | In distribution | |
| MX5815 | In distribution | |
| MX821L | In distribution | |
| MX20850 | In distribution | |
| MXG300152 | In distribution | |
| MX801 | In distribution | |
| MX20815 | In distribution | |
| MX20462 | In distribution | |
| SM5020 | In distribution | |
| MX6676 | In distribution | |
| FS117 | In distribution | |
| MX805 | In distribution | |
| MX6029 | In distribution | |
| MX448HF | In distribution | |
| MX7064 | In distribution | |
| MX20838 | In distribution | |
| MX448FMG | In distribution | |
| MX20896R1 | In distribution | |
| MXG300272 | In distribution | |
| MX6953 | In distribution | |
| MX834LB | In distribution | |
| MX20846R2 | In distribution | |
| MX837E | In distribution | |
| SM5021 | In distribution | |
| FS113 | In distribution | |
| MX824 | In distribution | |
| MXG300128 | In distribution | |
| MX20877 | In distribution | |
| MX448HFB | In distribution | |
| MX822S | In distribution | |
| MX830 | In distribution | |
| MX20816 | In distribution | |
| M20869R2 | In distribution | |
| MX823S | In distribution | |
| MX836 | In distribution | |
| MX20755 | In distribution | |
| MX870 | In distribution | |
| MX826 | In distribution | |
| MX821S | In distribution | |
| MX700312 | In distribution | |
| SM873 | In distribution | |
| MX815 | In distribution | |
| FS116 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 22 |
| Pall Posidyne® ELD Filter | Global Life Sciences Solutions USA LLC | 5 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
| Hemo-Nate | Utah Medical Products, Inc. | 3 |
| Filter, Infusion Line | Baxter Healthcare Corporation | 3 |
| Interlink | Baxter Healthcare Corporation | 3 |
| Pall Posidyne® NEO Filter | Global Life Sciences Solutions USA LLC | 2 |
| Hemo-TAP | Utah Medical Products, Inc. | 2 |
| Pall Supor® AEF Filter | Pall International Sàrl | 2 |
| Spectrum, Inc. | Spectrum Medical Ltd | 2 |
| WalkMed® | WalkMed Technologies, LLC | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
Showing 12 of 21. All products under Filter, Infusion Line
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 260 units |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 50 units |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 400 units |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 260 units |
| ICU Medical, Inc | 510(k) number | 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.